1. Technical Field
The present disclosure relates to an apparatus and method for closing a hole or puncture in a blood vessel, and, more particularly, to an apparatus for applying a suture assembly to a blood vessel to close a hole formed therein during an intravascular catheterization procedure.
2. Background of the Related Art
When performing a catheterization procedure such as, for example, an angiography or angioplasty, a sharpened hollow needle is first percutaneously introduced into the vascular system. A guide wire is then inserted through the hollow needle and into the lumen of a selected blood vessel. Subsequently, the needle is removed and a dilator and/or introducer is fed into the vessel along the guide wire. The guide wire is then removed and a suitable catheter is fed through the lumen of the introducer and advanced through the vascular system until the working end thereof is positioned at the operating site. At the conclusion of the catheterization procedure, the catheter is withdrawn, and subsequently, the dilator and/or introducer is also removed from the wound.
At this point in the procedure, the vessel puncture must be sealed in order to stem the flow of blood therethrough. Because it is often common practice to administer a blood thinning agent to the patient prior to the catheterization procedures, stemming the blood flow can be troublesome. A common method of healing the wound is to maintain external pressure over the vessel until the puncture naturally seals. This method of puncture closure typically takes about thirty minutes, with the length of time usually being greater if the patient is hypertensive or anti-coagulated.
When hand pressure is utilized, it can be uncomfortable for the patient and can use costly professional time on the part of the hospital staff. Other pressure application techniques, such as pressure bandages, sandbags or clamps, have been employed, but these devices also require the patient to remain motionless for an extended period of time and the patient must be closely monitored to ensure their effectiveness.
Other devices have been disclosed that plug or otherwise provide an obstruction in the area of the puncture. See, for example, U.S. Pat. Nos. 4,852,568 and 4,890,612, wherein a collagen plug is disposed in the blood vessel opening. When the plug is exposed to body fluids, it swells to create a block for the wound in the vessel wall. A potential problem of plugs introduced into the vessel is that particles may break off and float downstream to the point where they may lodge in a smaller vessel, causing an infarct to occur. Collagen material also acts as a nidus for platelet aggregation and, therefore, can cause intraluminal deposition of hemostatic agent, thereby creating the possibility of a thrombosis at the puncture site. Other plug-like devices are disclosed, for example, in U.S. Pat. Nos. 5,342,393; 5,370,660; and 5,411,520.
U.S. Pat. No. 5,417,699 to Klein et al. discloses a suture applying device for the percutaneous suturing of a vascular puncture site. The Klein '699 device includes a shaft which carries a pair of needles at its distal end. The needles are joined by a length of suture. The shaft is used to both introduce the needles within the lumen of the vessel and to draw the needle back through the vessel wall leaving a loop of suture behind to close the puncture site.
U.S. Pat. No. 5,527,322 to Klein et al. also discloses a suture applying device including a shaft having a nose piece attached at its distal end. A needle entry lumen in the shaft permits a flexible needle to be introduced in the distal direction. The deployed needle penetrates the tissue and enters a return lumen in the nose piece. The return lumen is U-shaped and acts to bend the flexible needle as it is advanced. In this way, the needle passes from the nose piece on the opposed side of a site. The needle then exits from the device, permitting the suture attached to the needle to be drawn fully through the device. The suture may then be tied in order to close and seal the tissue penetration.
Although the Klein '699 and Klein '322 devices offer several advantages in the closure of vascular openings, there are several shortcomings inherent to these devices which detract from their usefulness. In particular, the devices are generally complex requiring a multitude of moving parts and components. In addition, the Klein '699 device requires both needles to be complete introduced within the lumen of the blood vessel to be subsequently drawn through the vessel wall. This approach may not always be feasible or practical due to the limited accessibility of certain vessels.